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FDA 510(k)

Sterile Latex Surgical Gloves Powder Free

K-Number: K211478 · 2021-09-16

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-09-16
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Gloves Powder Free is a medical device manufactured by Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-16 under approval number K211478. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Aspen Glove Sdn. Bhd.. The 510(k) number is K211478.

When was Sterile Latex Surgical Gloves Powder Free approved by the FDA?

Sterile Latex Surgical Gloves Powder Free received FDA 510(k) clearance on 2021-09-16, under approval number K211478.

What company makes Sterile Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is manufactured by Aspen Glove Sdn. Bhd..

What is the FDA product code for Sterile Latex Surgical Gloves Powder Free?

The FDA product code for Sterile Latex Surgical Gloves Powder Free is KGO.

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Other Devices by Aspen Glove Sdn. Bhd.

K213076AspenMed+ K211477Latex Examination Powder Free Gloves K211479Blue Nitrile Examination Glove Powder Free

Related Devices (Code: KGO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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